Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery

Transthyretin Amyloidosis Clinical Trial

— CACTuS2  

Official title:

Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276220
• Other study ID #: 1-10-72-178-19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital Skejby
• Contact: Sie Kronborg Fensman
• Phone: +45 30 48 88 85
• Email: siefen[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.

If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.

Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Males above 65 years of age, females above 75 years of age.

• Scheduled idiopathic carpal tunnel release surgery.

• Informed written consent.

Exclusion Criteria:

• Operation by other indication, e.g.

• Fracture

• Ganglion

• Known amyloidosis

Related Conditions & MeSH terms

• Amyloidosis
• Transthyretin Amyloidosis
• Transthyretin Cardiac Amyloidosis
• Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Intervention

Diagnostic Test:
• Tenosynovial biopsy
Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Jylland

Sponsors (1)

Lead Sponsor	Collaborator
Steen Hvitfeldt Poulsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.	We will examine the amyloid deposits prevalence in biopsies from the Carpal Tunnel and ATTRwt prevalence in an aged and predominantly male population operated for idiopathic Carpal Tunnel Syndrom. Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both. Biopsies will be examined using Congo Red staining and fluorescent light	Through study completion, 6 years.
Secondary	Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis	We will investigate the plasma and urine levels of different forms of TTR (total TTR, misTTR, and fragTTR) in patients with amyloid deposits in the transverse carpal ligament, patients subsequently diagnosed with ATTRwt-CM and in patients with already diagnosed ATTRwt matched age and gender.; We will investigate whether the levels of TTR is higher among ligament amyloid positive patients that are subsequently diagnosed ATTRwt-CM as compared to those without ATTR-CM.	Has been added after study start, will run through study completion, 3 years.
Secondary	Comparing patients diagnosed with wild-type transthyretin cardiac amyloidosis due to screening with age and gender matched clinically diagnosed ATTRwt patients.	Compare NAC-stage, NYHA-class, LVEF ect.	Through study completion, 6 years.